Leprosy Active Searching Trial in Brazil

Pragmatic, Randomized, Cluster Stepped-Wedge Clinical Trial for Active Case Finding of Leprosy in Brazil

The goal of this clinical trial is to assess whether a multifactorial active case-finding strategy improves the detection of leprosy cases in Brazil compared to usual screening practices. The main questions it aims to answer are:

- Does the intervention increase the number of new leprosy cases detected compared to standard care?

Participants will:

• Receive community awareness about leprosy.
• Be screened using the Leprosy Suspicion Questionnaire at priority areas identified by georeference tools.
• Undergo clinical evaluation by a trained medical team.
• If leprosy is diagnosed, affected patients will collect complementary laboratory exams

Healthcare professionals from primary care units will receive training in leprosy, while researchers will monitor changes in leprosy incidence over a 12-month period using data from Brazil's national notification system. The study will provide insights into underdiagnosis and the clinical profiles of patients who have been diagnosed.

Inclusion Criteria:

(I) Municipalities

• Municipality recognized by the Brazilian Institute of Geography and Statistics as part of the Brazilian Federation.
• Municipality with operational epidemiological classification by the Ministry of Health (BMoH) as: 'municipalities with cases in the period from 2015 to 2019'.
• Municipality with authorization/consent from the government to participate in the study.

(II) Primary Health Units (Unidade Básica de Saúde or UBS) • UBS with territorial coverage (linked population) within the participating municipality.

(III) Participants

• Patients with positive Leprosy Suspicion Questionnaire (LSQ): children under five years old with Free and Informed Consent Form (ICF) signed by parents/guardians, 5-17 years old with ICF signed by parents/guardians and Free and Informed Assent Form (IAF) signed by the minor, and patients over 18 years old with ICF signed for: rapid test collection, comorbidity questionnaire and clinical evaluation; and if leprosy diagnosis is confirmed, collection of complementary exams.

Exclusion Criteria:

(I) Municipalities

• Municipality with extreme population size (municipalities with a number of inhabitants lower than the 10th percentile and higher than the 90th percentile).
• Municipality with operational epidemiological classification by the BMoH as: 'municipalities without cases in the period 2015 to 2019'.
• Municipalities with active or recent participation (less than one year) in other active-finding strategies, in addition to the usual ones: ministerial, Non-Governmental Organizations (NGOs), academic, among others.

(II) Primary Health Units

• UBS with limited multidisciplinary team (absence of physicians, nurse and/or community health agents).
• UBS with difficult access (no access by land, i.e. riverside populations).
• UBS with territorial coverage exclusively of indigenous populations.

(III) Participants

• LSQ negative.
• Patients with a previous diagnosis or history of treated leprosy.
• Patients residing/registered outside the selected municipality.